STERILITY TESTING ISOLATOR

FEATURES

• SUS316L stainless steel construction, 3 mm thick; 15 mm tempered-glass viewing window.

• Ergonomic design; ISO 4.8 cleanliness; comprehensive 4Q qualification services.

• Integrated temperature, humidity, differential pressure, air velocity, H₂O₂ concentration, airborne particle and viable monitoring.

• Online leak testing by pressure decay, meeting ISO 10648, ISO 14644 and PDA TR34 requirements.

TR34 data requirements

• System design complies with GMP, ISO, ISPE and pharmacopoeial requirements.

• Sterility testing zone configurable to process requirements.

• Optional WIP system for in-place chamber washing, pipeline rinsing and drying.

• Optional online electronic balance, with integrated data or independent operation.

• Optional RTP port, waste bin, transfer trolley and storage rack.

TECHNICAL SPECIFICATIONS

Cleanliness: Grade A (GMP compliant)

Sterility assurance level: SAL ≤ 10⁻⁶

Leak rate: Q/V ≤ 0.5%

Noise: ≤ 65 dB

Illuminance: ≥ 300 lux

Air velocity at openings: ≥ 0.5 m/s

Differential pressure: 0–80 Pa

APPLICATIONS

• Sterility testing

• Aseptic filling

• Aseptic compounding

• Aseptic cell culture